AR090776A1 - INJECTABLE PREPARATION, AND PREFERRED SYRINGE CONTAINING INJECTABLE PREPARATION - Google Patents

INJECTABLE PREPARATION, AND PREFERRED SYRINGE CONTAINING INJECTABLE PREPARATION

Info

Publication number
AR090776A1
AR090776A1 ARP130101321A ARP130101321A AR090776A1 AR 090776 A1 AR090776 A1 AR 090776A1 AR P130101321 A ARP130101321 A AR P130101321A AR P130101321 A ARP130101321 A AR P130101321A AR 090776 A1 AR090776 A1 AR 090776A1
Authority
AR
Argentina
Prior art keywords
salts
injectable preparation
aripiprazole
quinolin
piperazin
Prior art date
Application number
ARP130101321A
Other languages
Spanish (es)
Inventor
Hoshika Yusuke
Kaneko Daiki
Matsuda Takakuni
Original Assignee
Otsuka Pharma Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=48614096&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR090776(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharma Co Ltd filed Critical Otsuka Pharma Co Ltd
Publication of AR090776A1 publication Critical patent/AR090776A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/06—Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/24—Antidepressants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Inorganic Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Dermatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Dispersion Chemistry (AREA)
  • Pain & Pain Management (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)

Abstract

Reivindicación 1: Una preparación inyectable que comprende una composición que comprende un fármaco poco soluble, un medio de dispersión, y un agente de suspensión, caracterizada porque el agente de suspensión es, al menos, un miembro seleccionado entre el grupo compuesto por (i) e (ii): (i) polivinilpirrolidona, y (ii) polietilenglicol y carboximetilcelulosa o una de sus sales, y la composición tiene una viscosidad de 40 Pa×s o más en, al menos, un punto en el rango de velocidad de corte que oscila de 0,01 a 0,02 s⁻¹ y que tiene una viscosidad de 0,2 Pa×s o inferior, en al menos un punto en el rango de velocidad de corte que oscila de 900 a 1,000 s⁻¹, medido mediante un reómetro. Reivindicación 19: Un método para producir una jeringa prellenada, que se prellena con una composición en gel que comprende aripiprazol o una de sus sales, o 7-[4-(4-benzo[b]tioten-4-il-piperazin-1-il)butoxi]-1H-quinolin-2-ona, o una de sus sales, en el que dicho método consiste en: introducir en una jeringa una mezcla líquida que comprende aripiprazol o una de sus sales, o 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il)butoxi]-1H-quinolin-2-ona o una de sus sales en una concentración que oscila entre 200 y 600 mg/mL, agua, y al menos un agente de suspensión seleccionado entre el grupo que comprende (i) e (ii): (i) polivinilpirrolidona, y (ii) polietilenglicol y carboximetilcelulosa o una de sus sales, caracterizado porque el aripiprazol o una de sus sales, o la 7-[4-(4-benzo[b]tiofen-4-il-piperazin-1-il) butoxi]-1H-quinolin-2-ona o una de sus sales tienen un diámetro de partícula primario promedio que oscila entre 0,5 y 30 mm, y dejar reposar la mezcla líquida de 5 a 70ºC durante 5 minutos o más.Claim 1: An injectable preparation comprising a composition comprising a poorly soluble drug, a dispersion medium, and a suspending agent, characterized in that the suspending agent is at least one member selected from the group consisting of (i) and (ii): (i) polyvinylpyrrolidone, and (ii) polyethylene glycol and carboxymethyl cellulose or one of its salts, and the composition has a viscosity of 40 Pa × s or more in at least one point in the cutting speed range that It ranges from 0.01 to 0.02 s⁻¹ and has a viscosity of 0.2 Pa × s or less, at least one point in the cutting speed range that ranges from 900 to 1,000 s⁻¹, measured by a rheometer Claim 19: A method of producing a prefilled syringe, which is prefilled with a gel composition comprising aripiprazole or a salt thereof, or 7- [4- (4-benzo [b] tioten-4-yl-piperazin-1 -yl) butoxy] -1H-quinolin-2-one, or one of its salts, wherein said method consists in: introducing into a syringe a liquid mixture comprising aripiprazole or one of its salts, or 7- [4- (4-benzo [b] thiophen-4-yl-piperazin-1-yl) butoxy] -1H-quinolin-2-one or a salt thereof in a concentration ranging from 200 to 600 mg / mL, water, and at least one suspending agent selected from the group comprising (i) e (ii): (i) polyvinylpyrrolidone, and (ii) polyethylene glycol and carboxymethyl cellulose or one of its salts, characterized in that aripiprazole or one of its salts, or the 7- [4- (4-benzo [b] thiophen-4-yl-piperazin-1-yl) butoxy] -1H-quinolin-2-one or one of its salts has an average primary particle diameter ranging from 0 , 5 and 30 mm, and let stand the liquid mixture of 5 to 70 ° C last You 5 minutes or more.

ARP130101321A 2012-04-23 2013-04-22 INJECTABLE PREPARATION, AND PREFERRED SYRINGE CONTAINING INJECTABLE PREPARATION AR090776A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201261636938P 2012-04-23 2012-04-23
US201361792089P 2013-03-15 2013-03-15

Publications (1)

Publication Number Publication Date
AR090776A1 true AR090776A1 (en) 2014-12-03

Family

ID=48614096

Family Applications (1)

Application Number Title Priority Date Filing Date
ARP130101321A AR090776A1 (en) 2012-04-23 2013-04-22 INJECTABLE PREPARATION, AND PREFERRED SYRINGE CONTAINING INJECTABLE PREPARATION

Country Status (32)

Country Link
US (8) US20150093442A1 (en)
EP (2) EP2841054B2 (en)
JP (6) JP6234996B2 (en)
KR (4) KR20210116702A (en)
CN (3) CN114344259B (en)
AR (1) AR090776A1 (en)
AU (4) AU2013253374B2 (en)
BR (1) BR112014026307B1 (en)
CA (2) CA3120297A1 (en)
CO (1) CO7151500A2 (en)
CY (1) CY1122252T1 (en)
DK (1) DK2841054T4 (en)
EA (1) EA026619B1 (en)
ES (1) ES2743706T5 (en)
HK (2) HK1206988A1 (en)
HR (1) HRP20191366T4 (en)
HU (1) HUE045979T2 (en)
IL (1) IL235299B (en)
JO (2) JOP20200109A1 (en)
LT (1) LT2841054T (en)
MX (1) MX359241B (en)
MY (2) MY198007A (en)
NZ (1) NZ630335A (en)
PH (2) PH12014502379B1 (en)
PL (1) PL2841054T5 (en)
PT (1) PT2841054T (en)
SG (3) SG10201913425VA (en)
SI (1) SI2841054T2 (en)
TW (5) TW202126303A (en)
UA (1) UA115444C2 (en)
WO (1) WO2013162048A1 (en)
ZA (1) ZA201407335B (en)

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Also Published As

Publication number Publication date
PL2841054T3 (en) 2019-10-31
PH12019500498A1 (en) 2020-03-02
JP2019070028A (en) 2019-05-09
CN108186556A (en) 2018-06-22
US20150093442A1 (en) 2015-04-02
KR20210116702A (en) 2021-09-27
KR20240068788A (en) 2024-05-17
AU2022241491A1 (en) 2022-10-20
PT2841054T (en) 2019-09-09
SG10201913425VA (en) 2020-03-30
TW201350136A (en) 2013-12-16
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